Information:
Error:
ID
21782
Description
Treatment-Resistant Depression Registry; ODM derived from: https://clinicaltrials.gov/show/NCT00320372
Link
https://clinicaltrials.gov/show/NCT00320372
Keywords
Versions (1)
- 4/30/17 4/30/17 -
Uploaded on
April 30, 2017
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Major Depressive Disorder NCT00320372
Eligibility Major Depressive Disorder NCT00320372
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00320372
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Single major depressive episode
Item
patient diagnosed with a current major depressive episode according to dsm-iv-tr criteria.
boolean
C0024517 (UMLS CUI [1])
Clinical Trial Specified Completed
Item
for d-21 patients only who have completed the d-21 dosing study without any d-21 inclusion and exclusion protocol deviation.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Depressive episode Duration | Depressive episode Lifetime Quantity | Single major depressive episode
Item
patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current mde.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0349217 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024517 (UMLS CUI [3])
C0449238 (UMLS CUI [1,2])
C0349217 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024517 (UMLS CUI [3])
Antidepressant therapy Quantity Poor response to treatment
Item
patient has had an inadequate response to 4 or more adequate antidepressive treatments.
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
Illness Moderate Clinical Global Impression Questionnaire
Item
the patient has a cgi severity of illness score of moderately ill (score of 4) or greater.
boolean
C0221423 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639708 (UMLS CUI [1,3])
C0205081 (UMLS CUI [1,2])
C3639708 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
the patient must be able to provide informed consent and complete all forms.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
Schizophrenia | Schizoaffective Disorder | Psychotic Disorders | Severe major depression, single episode, with psychotic features | Psychotic state
Item
patient has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0154406 (UMLS CUI [4])
C0459435 (UMLS CUI [5])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0154406 (UMLS CUI [4])
C0459435 (UMLS CUI [5])
Enrollment Clinical Trial Double-Blind Method
Item
patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind d-21 study will be allowed to enter the registry for long term follow-up
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
Vagus Nerve Stimulation
Item
other than those patients who were enrolled in the d-21 study, patient has previously received vns therapy.
boolean
C2350432 (UMLS CUI [1])
Rapid cycling bipolar I disorder
Item
patient has a history of rapid cycling bipolar disorder.
boolean
C2063820 (UMLS CUI [1])